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Carpentier-Edwards PERIMOUNT Plus Mitral Pericardial Bioprosthesis
The Carpentier-Edwards PERIMOUNT mitral pericardial bioprosthesis was introduced into clinical use in Europe and Canada in 1984 and approved for US distribution in 2000. Its unique design maximizes durability and enhances hemodynamic performance (Figure 1).
The Carpentier-Edwards PERIMOUNT Plus mitral pericardial bioprosthesis is implanted using standard surgical techniques. The standard implantation technique includes: 1. Proper sizing 2. Proper seating of the prosthesis 3. Tying sutures with the holder in place to avoid suture looping or chordal entrapment 4. Examination of the valve leaflets for distortion or leak during tying The Carpentier-Edwards PERIMOUNT Plus mitral pericardial bioprosthesis has an innovative low profile design with short struts as compared to porcine valves. This feature minimizes the risk of left ventricular outflow tract obstruction by the prosthesis and the risk of ventricular damage in patients with a small ventricular cavity (Figure 3). Nonetheless, as with any stented mitral bioprosthesis, special care must be taken during implantation to avoid looping a suture around one of the strut posts or inserting a post behind a strand of chordal tissue when chordal preservation techniques are used.
Figure 1 Carpentier-Edwards PERIMOUNT Plus Pericardial Mitral Bioprosthesis
The valve profile, shape and leaflet mounting technique were engineered to enhance durability by increasing tolerance for the high pressure under which a mitral bioprosthesis functions. Clinical studies of the mitral PERIMOUNT valve demonstrate excellent freedom from structural valve deterioration1,2 (Figure 2).
Freedom From Explant Due to SVD
90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
99% 92% 89%
Actual freedom at 15 years for patients ≥ 70 years is 98.9 ± 1.1% Actual freedom at 16 years for patients ≥ 65 years is 92.4 ± 2.2% Actual freedom at 16 years for patients ≥ 60 years is 88.7 ± 2.4% Carpentier-Edwards PERIMOUNT Plus Mitral Bioprosthesis Carpentier-Edwards Porcine Bioprosthesis
Total Profile Height
N= 99 80 77 73 71 65 59 49 46 36 29 22 N= 188 160 153 147 143 131 120 104 98 82 72 57 N= 278 238 228 219 212 196 183 164 157 135 123 101 16 38 67 8 21 41 3 10 25 1 5 12 2 4
Figure 3 Comparison of 27 mm Valves
Figure 2 Actual Freedom From Explant Due to SVD
3 When using this technique. Valve Holder The Tricentrix holder system provides ease of use and increased visibility. The three stent posts retract toward the center of the valve when the Tricentrix holder system is fully deployed. then push on the handle until the post snaps into its fully deployed position (Figure 6). there should be no space between the base of the white post and the holder.8 1.2 1. it is recommended that the surgeon sizes the valve after sutures have been placed to ensure that sizing is more accurate and to avoid placing too large a valve.9 0 n= 25 mm 3 27 mm 40 29 mm 47 31 mm 27 33 mm 4 0 Valve Size Once the handle has been attached. Maintain the valve placement in the annulus by gently placing forceps or gloved hands onto the holder. Figure 4 Sizer Model 1169P The sizer should fit comfortably in the annulus.Check for proper deployment: the holder should be locked. Chordal preservation techniques may decrease the size of valve that can be implanted.7 1. Prior to tying the sutures. Figure 8 . Rotate Figure 6 Push . Sizer dimensions correlate with those of the valve (Figure 4). In-vitro Pressure Drop at 5 l/min7 mmHg 2. Oversizing Oversizing may cause valve damage or localized mechanical stresses.3 2. Cut the adapter attachment thread by the handle (Figure 8) and remove the adapter and handle assembly as one unit. . Rinse the valve two times. the preserved leaflets are reefed within the valve-sutures and compressed between the sewing ring and the native annulus. With chordal sparing.4 1. The lip of the sizer mimics the valve sewing ring and helps the surgeon to anticipate the outcome of specific implantation techniques. which may in turn injure the heart or result in tissue failure. This is easily achieved without unscrewing it: the handle and adapter can be removed as an assembly. it should not be removed from the holder until the valve is seated in the annulus.1. the handle of the valve holder may be removed.4 1.Insert the handle 1111 (reusable) or 1126 (disposable) and turn clockwise until snug fit.6 1.1 1.3 1. The excellent hemodynamic performance of the mitral PERIMOUNT Plus valve across all sizes makes oversizing unnecessary (Figure 5).8 0.8 2.6 2. thereby decreasing the size of the annulus. . one minute each. it is essential to leave the valve holder attached to the valve while tying the sutures. the scrub nurse should follow these steps: .Remove the sleeve and clip.6 0. Figure 5 Hemodynamic Performance 2. stent distortion and valve regurgitation. To deploy the Tricentrix holder system. in separate saline bowls filled with at least 500 ml. However.6 2.4 Check Rotate • Push • Snap Push • Snap Implant Figure 7 Check for Proper Deployment In-vitro Clinical EOA at 1-2 yr post implant8 cm2 3. Its innovative tenting system protects the struts from entrapping a loose suture or chordae.Grasp the plastic sleeve and rotate the handle clockwise until the holder reaches the unlock position.5 2. Sizing It is essential to use the 1169P sizers designed for the mitral PERIMOUNT Plus valve. remove the cap. and no sliding movement (Figure 7).6 2.
along with attaching sutures using sterile gloved hands or protected forceps (Figure 10). Suture Technique Like other mitral bioprostheses. then removing the holder system as a unit. and up through the prosthesis sewing ring. The valve should be positioned to avoid obstruction of the left ventricular outflow tract by the struts. Valve Orientation Two suture markers aid in the orientation of the valve. The mitral PERIMOUNT Plus valve is symmetrical and offers three identical leaflets without muscle shelves. around the free edge of the mitral leaflet. examine the valve leaflets while holding the two strands of the suture under tension. . The holder is easily removed by cutting each of the three green exposed threads using a scalpel or scissor placed in the cutting channel.4 Maintain firm tension on the sutures as the valve is lowered into the annulus to prevent formation of suture loops that might entrap a leaflet. the holder can no longer prevent suture looping around the stent posts. the mitral PERIMOUNT Plus valve is usually implanted using pledgeted mattress sutures. Figure 11 Avoid suture looping If leaving the holder in place obstructs the surgeon's view. Distortion or movement of the valve leaflets during this maneuver suggests that the suture is looped around a strut.3. If the deployed holder attachment threads are cut before these adjacent sutures are tied down. Assessment of Sutures Before tying each suture. The valve is seated and the sutures tied. Figure 10 Atrial Placement Figure 9 Ventricular Placement With chordal-preserving techniques. loosening the sutures which may in turn result in a suture loop. 5. Removal of the Valve Holder To avoid suture looping. all the sutures adjacent to each of the three stent posts MUST be tied down before cutting the three holder attachment threads to remove the holder. A surgical mirror may be placed through the valve leaflets in order to ensure proper suture placement (Figure 11). the valve could also unseat or partially separate from the annulus during the removal of the holder. If leaflet movement or distortion is observed. horizontal mattress valve sutures are passed from the left atrium. through the mitral annulus. it is essential to leave the deployed holder in place until all knots are tied. Ventricular placement is sometimes preferred in the case of a calcified annulus (Figure 9). reefing the native leaflets and compressing them between the sewing ring and native annulus. 4. Without these attachment sutures. Special attention must be given to avoid tying the sutures on top of the corners of the holder legs. The pledgets may be placed either on the atrial or ventricular aspect of the annulus. the strut closest to the suture is examined and the suture slipped off the strut. pledget-reinforced 6.
S. · 1290 Central Pkwy West. · Ch. Mitral valve replacement with complete mitral leaflet retention: operative techniques. Model 6900 CLINICAL COMMUNIQUE 3 Aagaard J. 7. Data on file at Edwards Lifesciences .4220 · 800.6 Abnormal flow patterns include moderate (2+) or greater central or eccentric regurgitation. the ventricular aspect of the valve should be examined with a surgical mirror in order to ensure correct suture placement and no suture or chordal entrapment. PERIMOUNT and PERIMOUNT Plus are trademarks of Edwards Lifesciences Corporation and are registered in the U.5213.al.250.268.69:135-139. Mitral valve replacement with total preservation of native valve and subvalvular apparatus. as the patient returns to physiologic Edwards Lifesciences LLC · One Edwards Way · Irvine. The Cleveland Clinic Foundation.A. Ann Thorac Surg 2000. The leaflets should appear symmetric.com Edwards Lifesciences (Canada) Inc. the stylized E Logo and Tricentrix are trademarks of Edwards Lifesciences Corporation.4300 Edwards Lifesciences Japan · 2-8 Rokubancho · Chiyoda-ku. 12:884-900 6.424.edwards. Ontario · Canada L5C 4R3 · Phone 905. et al.3278 · www.D. Fifteen-Year Experience With the Mitral Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis.21. the ventricle is filled with saline under pressure to assess valve function. In such an instance. Similarly. Surgical photos courtesy of Delos Cosgrove. pressures following cardiopulmonary bypass.5700 . intraoperative post-bypass transesophageal echo verification of valve function prior to heparin reversal and decannulation is essential. and there is usually a small central jet of regurgitation. 1999 Jan. See the instructions for use that accompany the product for full prescribing information.D. Carpentier-Edwards PERIMOUNT Plus Mitral Pericardial Bioprosthesis product insert Directions for use. et. Ann Thorac Surg 2001. J Am Soc Echocardiogr 1999. du Glapin 6 · 1162 Saint-Prex · Switzerland · Phone 41..3. Leaflet distortion or a major jet arising elsewhere suggests a technical problem.5 Normally functioning valves demonstrate no or mild central regurgitation arising from the free space at the center of the valve.RD346 8. Unlike the signature flow pattern. Patent and Trademark Office. All of these flow patterns are physiologically insignificant and comprise this valve’s signature flow pattern (Figure 12). especially severe regurgitation or a restricted appearance of the leaflets on echocardiographic assessment may indicate an entrapped leaflet and requires reinstitution of cardiopulmonary bypass and re-opening of the atrial incision for further assessment. M. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity. © 2004 Edwards Lifesciences LLC All rights reserved. Suite 300 · Mississauga. Excessive regurgitation. Edwards Lifesciences.Special Considerations After all sutures are tied. Tokyo 102-0085 · Japan · Phone 81. AR00639 Additional flow patterns observed include minor jets originating from the sewing ring cloth that may be observed prior to administration of protamine.566. 2 Data on file at Edwards Lifesciences . Edwards Lifesciences does not endorse any particular surgical technique. 71:S236–9. these jets typically resolve shortly after reversal of heparin.8(1):44-6 5. References 1 Marchand MA.3993 Edwards Lifesciences S. Figure 12 Signature Flow Pattern: Trivial MR Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Morehead AJ et al. Carpentier-Edwards. the appearance of the central jet diminishes until only trivial or mild signature flow remains. Edwards. Introperative echocardiographic detection of regurgitant jets after valve replacement. 1997 May. Marc Gillinov. The surgical technique presented in this paper is the technique developed by A. Antegrade cardioplegia may also be administered to pressurize the left ventricle. Shanewise JS et al: ASE/SCA guidelines for performing a comprehensive intraoperative multiplane transoesophageal echocardiography examination: Recommendations of the American Society of Echocardiography Council for Intraoperative Echocardiography and the Society of Cardiovascular Anaesthesiologists Task Force for Certification in Perioperative Transeosophageal Echocardiography. J Heart Valve Dis. CA 92614 USA · 949. J Heart Valve Dis. See instructions for use for full prescribing information.823.2500 · 800.16 YEAR RESULTS Carpentier-Edwards PERIMOUNT Mitral Pericardial Bioprosthesis. Echocardiographic Assessment As with any heart valve operation. M. et al. discussion 279-80 4 Yu Y. Occasionally one or more trivial jets arise from the coaptation edge of the leaflets and originate at the stent posts.6(3):274-8.
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